Poronal

PACKAGE LEAFLET: INFORMATION FOR THE USER

PORONAL 70 mg film-coated tablets

Alendronic acid
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• It is particularly important to understand the information contained in section
  3. HOW TO TAKE PORONAL, before taking this medicine.

Contents of this leaflet:

1. What PORONAL is and what it is used for
2. What you need to know before taking PORONAL
3. How to take PORONAL
4. Possible side effects
5. How to store PORONAL
6. Contents of the pack and other information

1. WHAT PORONAL IS AND WHAT IT IS USED FOR

What is PORONAL?
PORONAL belongs to a group of non-hormonal medicines called bisphosphonates.
PORONAL prevents the loss of bone tissue that occurs in women after
menopause and promotes bone rebuilding. It reduces the risk of vertebral and
hip fractures.
What is PORONAL used for?
Your doctor has prescribed PORONAL for the treatment of osteoporosis. PORONAL reduces
the risk of vertebral and hip fractures.
PORONAL is a treatment to be taken once a week.
What is osteoporosis?
Osteoporosis is thinning and weakening of the bones. It is common in women
after menopause. During menopause, the ovaries stop producing female hormones,
estrogens, which help maintain a woman's skeletal health. As a result,
bone tissue is lost and bone becomes weaker. The risk of
osteoporosis is greater the earlier a woman reaches menopause.
In its early stages, osteoporosis usually causes no symptoms. However, if left
untreated, fractures may occur. Although fractures are typically painful,
vertebral fractures may go unnoticed until they result in a loss of height. Fractures can
occur during normal daily activities such as lifting weights, or following minor trauma
that would not cause fractures in normal bone. Fractures usually occur in the
hip, spine, or wrist and can be not only painful but may lead to significant deformities and disability, such as
curvature of the back (dowager's hump) and movement limitations.
How can osteoporosis be treated?
Along with treatment with PORONAL, your doctor may recommend lifestyle changes to improve the condition, such as:
Quitting smoking: smoking appears to increase the rate at which bone tissue is lost
and therefore may increase the risk of fractures.
Physical exercise: like muscles, bones need physical activity to stay
strong and healthy. Consult your doctor before starting
any exercise program.
Balanced diet: your doctor can provide information about diet or the possible
need for dietary supplements (especially calcium and vitamin D).

2. WHAT YOU SHOULD KNOW BEFORE TAKING PORONAL

Do not take PORONAL:

1. If you are allergic (hypersensitive) to sodium alendronate trihydrate or to any of the other ingredients of this medicine (listed in section 6).
2. If you have certain diseases of the esophagus (the tube connecting the mouth to the stomach), such as narrowing or difficulty swallowing.
3. If you are unable to stand or sit upright for at least 30 minutes.
4. If your doctor has told you that you have low levels of calcium in your blood.

If you think any of these situations apply to you, do not take the tablets. Consult your doctor and follow the instructions given.

Warnings and precautions

Talk to your doctor or pharmacist before taking PORONAL if:

• you have Barrett’s esophagus (a condition associated with changes in the cells lining the lower part of the esophagus)
• you have kidney problems
• you suffer from allergies
• you have difficulty swallowing or gastrointestinal disorders
• you have low levels of calcium in your blood
• you have been diagnosed with a condition affecting mineral absorption in the stomach or intestine (malabsorption syndrome)
• you have poor dental health, gum disorders, are scheduled for a tooth extraction, or do not regularly undergo dental care
• you are or have been a smoker (as this may increase the risk of dental problems)
• you have cancer
• you are taking anti-angiogenic agents (such as bevacizumab or thalidomide) used in cancer treatment
• you are undergoing chemotherapy or radiotherapy
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, or severe allergies

You may be advised to have a dental examination before starting treatment with PORONAL, especially if any of the above conditions apply to you.

During treatment with PORONAL, appropriate preventive dental procedures should be followed as recommended by your dentist.

It is important to maintain good oral hygiene during treatment with PORONAL. You should have regular dental check-ups throughout the treatment and contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulceration of the esophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, burning sensation in the upper stomach, or difficulty or pain when swallowing—especially if patients do not drink a full glass of water and/or lie down within the first 30 minutes after taking PORONAL. These side effects may worsen if patients continue taking PORONAL after experiencing such symptoms.

Children and adolescents

PORONAL must not be given to children and adolescents under 18 years of age.

Other medicines and PORONAL

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Calcium supplements, antacids, and certain oral medications may interfere with the absorption of PORONAL if taken at the same time.

Therefore, it is important to follow the instructions provided in section 3.

Some medicines used for rheumatic conditions or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medicines together with PORONAL.

PORONAL with food and drink

Food and beverages (including mineral water) may reduce the effectiveness of PORONAL if taken at the same time. Therefore, it is important to follow the instructions given in section 3.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

PORONAL is intended only for postmenopausal women. Do not take PORONAL if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines

With PORONAL, undesirable effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect the ability to drive or operate machinery (see section 4).

PORONAL contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. HOW TO TAKE PORONAL

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one PORONAL tablet once a week.
Follow carefully the instructions below:

1. Choose the day of the week that best fits your routine. Take one PORONAL tablet once a week on the chosen day.
   It is very important that you follow steps 2), 3), 4), and 5) to help the PORONAL tablet reach the stomach quickly and help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. After getting up in the morning to start your day, and before taking any food, drink, or other medicines, swallow the PORONAL tablet whole with a full glass of tap water only (not mineral water) (no less than 200 ml), so that PORONAL is properly absorbed.

• Do not take it with mineral water (still or sparkling)
• Do not take it with coffee or tea
• Do not take it with fruit juices or milk

Do not chew or crush the tablet and do not let it dissolve in the mouth, as this may cause mouth ulcers.
3) Do not lie down – remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4) Do not take PORONAL at bedtime or just before getting up in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking PORONAL and contact your doctor.
6) After swallowing the PORONAL tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. PORONAL is effective only when taken on an empty stomach.

If you take more PORONAL than you should:
If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take PORONAL:
If you forget to take the tablet, simply take one PORONAL tablet the following morning. DO NOT take two tablets on the same day. Afterwards, resume taking the tablet on your chosen day of the week.

If you stop taking PORONAL:
It is important to continue taking PORONAL for as long as prescribed by your doctor. PORONAL is effective in treating osteoporosis only if you continue taking the tablets.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following adverse effects,
which may be serious and for which you may require urgent medical treatment:

Very common (may affect more than 1 in 10 people):

• bone, muscle, and/or joint pain, sometimes severe.

Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; esophageal ulcers (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, or difficulty or pain when swallowing,
• joint swelling,
• abdominal pain; stomach discomfort or belching after meals; constipation; sensation of fullness or bloating in the stomach; diarrhea; intestinal gas,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,
• irritation or inflammation of the esophagus (the tube connecting the mouth to the stomach) or stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; skin redness,
• flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
• taste disturbances.

Rare (may affect up to 1 in 1,000 people):

• allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, possibly causing difficulty breathing or swallowing,
• symptoms due to low calcium levels in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• peptic or stomach ulcers (sometimes severe or with bleeding),
• narrowing of the esophagus (the tube connecting the mouth to the stomach),
• skin rash worsened by exposure to sunlight; severe skin reactions,
• mouth pain, and/or jaw pain, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw, or tooth loss. These could be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual fracture of the femur may occur, particularly in patients undergoing long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this may be an early sign of a possible femoral fracture,
• mouth ulcers,
• severe bone, muscle, and/or joint pain.

Very rare (may affect up to 1 in 10,000 people):

• Contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These events could be signs of bone damage in the ear.

Not known (frequency cannot be determined from available data):

• unusual fractures occurring at sites other than the femur.

Promptly inform your doctor or pharmacist if you experience any of these symptoms or
any other unusual symptoms.
It is advisable to record any symptoms that occur, including when they started and how long they lasted.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PORONAL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
Do not remove the tablets from the blister pack before it is time to take them.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What PORONAL contains
Active substance
The active substance is sodium alendronate trihydrate. Each tablet contains the equivalent of alendronic acid 70 mg as sodium alendronate trihydrate.
Excipients
Core: microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate;
Coating: hypromellose, talc.
Description of the appearance of PORONAL and contents of the package
Film-coated tablets: pack containing 4 tablets.
Marketing Authorization Holder
Konpharma s.r.l.,
Via Pietro Della Valle 1,
00193 Rome
Italy
Manufacturers
Special Product’s Line S.p.A.
Strada Paduni, 240 – 03012 Anagni (FR) Italy
LACHIFARMA S.P.A. Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Zona Industriale, 73010 Zollino (LE) – Italy